To ensure full compliance with applicable laws, regulations, and best practices, this working package defines an ethical framework and oversight structure guiding all research and device development activities. An ethics committee will be convened to review protocols, informed-consent materials, data-protection measures (e.g., GDPR compliance), and patient-safety procedures, providing guidance and approval at key milestones. Continuous monitoring and reporting mechanisms will be implemented to address any emerging ethical issues throughout the project lifecycle.